Full Prescribing Info
Cloxacillin sodium.
Each capsule contains: Cloxacillin (as Sodium) 500 mg.
Each 5 mL (1 teaspoonful) contains: Cloxacillin (as Sodium) 125 mg.
Cloxacillin sodium is a white odorless, hygroscopic, crystalline powder. Soluble 1 in 2.5 of water and 1 in 30 of alcohol slightly soluble in chloroform.
Pharmacology: Absorption and Fate: Cloxacillin sodium is incompletely absorbed from the gastrointestinal tract after oral administration, and absorption is further reduced by the presence of food in the stomach. After an oral dose of 500 mg, a peak plasma concentration of 7 to 12 μg per mL is obtained in fasting subjects in 1 to 2 hours. Absorption is more complete when given by intramuscular injection and peak plasma concentrations of about 15 μg per mL have been observed 30 minutes after a dose of 500 mg. Doubling the dose can double the plasma concentration. About 95% of Cloxacillin sodium in the circulation is bound to plasma proteins. Cloxacillin sodium has been reported to have a plasma half-life of approximately 0.5 hour in healthy subjects.
Cloxacillin sodium is metabolized to a limited extent and the unchanged drug is excreted in the urine by glomerular filtration and up to 10% in the bile.
Cloxacillin sodium is an isoxazoyl penicillin used for the treatment of infections due to staphylococci resistant to benzylpenicillin, including infections of the skin and soft tissues, bones, and joints, respiratory tract and urinary tract; otitis media, endocarditis. septicemia, and meningitis. It is also used for mixed streptococcal infections when the staphylococci are penicillin resistant. It is also used for the prophylaxis of staphylococcal infections during major surgical procedures, particularly in cardiothoracic and orthopaedia surgery.
Dosage/Direction for Use
Capsule: One (1) capsule four (4) times a day or as prescribed by the physician. To be taken about 1 hour before meals.
Powder for Solution Children: up to 2 years of age: 5 mL (1 teaspoonful); 3 years up to 10 years old: 10 mL (2 teaspoonfuls).
To be taken every 4 to 6 hours or as prescribed by the physician.
Special Precautions
Patients known to be hypersensitive to penicillin should be given an antibiotic of another class. However, sensitized patients may also react to cephalosporins. Penicillin should be given with caution to patients with a history of allergy, especially to other drugs.
Adverse Reactions
The most common adverse effect of Cloxacillin sodium are allergic reactions and of these, skin rashes occur most frequently. Administration to a hypersensitive patient may occasionally result in anaphylactic shock with collapse and sometimes death occurring within minutes; angioedema or bronchospasm may occur.
Caution For Usage
Direction for Reconstitution: To make 60 mL reconstituted solution mix thoroughly the contents with 39 mL water and shake well until the powder is evenly suspended. The reconstituted solution is stable for 7 days at temperatures not exceeding 30°C and 14 days when refrigerated (2-8°C).
Store at temperatures not exceeding 30°C.
Shake well before use.
MIMS Class
ATC Classification
J01CF02 - cloxacillin ; Belongs to the class of beta-lactamase resistant penicillins. Used in the systemic treatment of infections.
Cap 500 mg x 100's. Powd for oral soln 125 mg/5 mL x 60 mL.
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